Drug risks raise doubt about ads

As the list of prescription drugs raising concern about possible harmful side effects grows, new questions are being asked about the wisdom of inundating consumers with a blizzard of ads for medicines whose safety or effectiveness may later be called into question.

And make no mistake: Advertising pills directly to American consumers on television and in print has been a spectacular success for drug companies. Direct-to-consumer drug advertising has mushroomed from nothing in 1985 into a $3.8-billion-a-year business today. Some 44 percent of Americans now take at least one drug daily, as opposed to 39 percent a decade ago.

To be sure, this mass culture of medicine may be prone to overreaction in both directions. While many critics decry the proclivity of Americans to pop a pill at the slightest hint of a symptom - in part because of the influence of advertising - others note that people often flee from a drug at the first sign of safety problems, even if the safety studies are far from conclusive. At last one drug trial has had to be canceled only because patients testing the drug refused to keep taking it.

To help curb the overuse of drugs, some critics are renewing their call for a ban on consumer advertising altogether, which many believe is impossible, in part because the ads are protected by the First Amendment as commercial free speech.

In the absence of such a move, critics say the drug companies should at least be more heavily regulated and their commercials required to stick to the scientific facts and not be allowed to subtly imply greater claims.

"I don't think there's any question that direct-to-consumer advertising stimulates sales. If it didn't, companies wouldn't do it," says Sidney Wolfe, the director of health research at the consumer group Public Citizen.

Drugmakers and their watchdog, the Food and Drug Administration, say consumer ads provide helpful information to consumers. But critics see the mission of the industry differently: It's simply to sell drugs.

"Its [aim is] no more to improve our health than it is the fast-food industry's mission to improve our diet," says Dr. John Abramson, a physician critical of the drug industry and author of "Overdosed America."

"Unfortunately the advertising gets handled by the same companies that market soft drinks and shampoos and automobiles and they bring the same light-hearted, image-conscious approach...," says Jerry Avorn, a professor at Harvard Medical School and author of "Powerful Medicines: the Benefits, Risks, and Costs of Prescription Drugs."

In the end, they're just drugs, not solutions for living happier lives, he says. A higher standard should be asked "for chemicals that you put in your body to change the way your cells work," he says. "It ought to be more science driven and less image driven."

The millions of people using Vioxx, a pain reliever pulled from the market because of health concerns in September, "was a direct result of consumer advertising," Dr. Avorn says. "Direct-to-consumer advertising ensures that the greatest number of patients will be exposed to a drug at the very moment we know the least about it."

He and others say companies want to hype drugs right after they are approved for use by the FDA, while they still own the patent. Doctors are often pressured by patients to prescribe the drug, even threatening to go to another physician who will prescribe it.

By asking about advertised drugs, patients can see themselves as empowered and participating more in their own health care. But there's a downside to that. "At a time when the doctor-patient visit is increasing short, on average about 10 minutes," Avorn says, these discussions can "eat up several of those precious minutes" with patients saying "I think I need Drug X I saw on television last night." Doctors have little time with patients as it is, he says, and don't want to spend it "trying to talk patients out of taking drugs they don't need."

An in-depth discussion about changes in lifestyle - more exercise, quitting smoking, better diet, weight loss - is sacrificed for scribbling out a quick prescription. "They leap right to a pill," Dr. Wolfe says.

Drugmakers are under siege as they see clinical trials of their products halted, ads pulled for exaggerated or inaccurate claims, or drugs even taken off the market altogether. Vioxx was pulled off the market in September because of concerns that it increased the risk of heart attack and stroke. It was the biggest prescription drug recall in history: 20 million people were taking Vioxx, and worldwide sales had shot to $2.5 billion. Questions have now been raised about Bextra, and the National Cancer Institute stopped a clinical trial of Celebrex due to health concerns.

For its part, PhRMA, the drug industry lobby, defends the quality of drug advertisements. a"We have confidence in the regulation of direct-to-consumer advertising by the Food and Drug Administration," says spokesman Jeff Trewhitt. The FDA "aggressively monitors" the ads, he says, and in the case of more than 90 percent of the ads going on television, drug companies voluntarily submit them for advanced review by the FDA, he says.

Unlike other consumer ads, drug ads also must by law disclose side effects, Mr. Trewhitt notes. Sometimes those side effects "are rather gruesome, and that is part of the ad."

The US and New Zealand remain the only countries where drugs can be marketed directly to consumers, Wolfe says. He and other critics would like to see a stronger role by the FDA. Instead, he says, the reverse is happening: In 1998 the FDA asked that 157 drug ads be withdrawn; last year, that fell to just 23 requests.

From articles and ads aimed at doctors in medical journals to consumer ads, "Everywhere we turn for legitimate information the drug companies are having too much influence," Abramson says.

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